CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,203 enrolled
Drug / intervention
Lutein/zeaxanthin and DHA/EPA +2 moredrug
Likely dose
Lutein/zeaxanthin and DHA/EPA 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00345176
NCT00345176Phase 3Completed
CompareCT.gov

Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration

National Eye Institute (NEI)·interventional·Posted Jun 27, 2006·Updated May 5, 2015

In Brief

A Phase 3 clinical trial evaluating Lutein/zeaxanthin, DHA/EPA, and 1 other intervention for Age-related Macular Degeneration and Cataract. Completed, enrolled 4,203 participants across 91 sites.

Detailed Summary

Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge-related Macular Degeneration, Cataract
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS), National Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2006
Enrollment StartSep 1, 2006
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.0 years ago

Interventions

Lutein/zeaxanthindietary

10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules)

DHA/EPAdietary

Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)

Lutein/zeaxanthin and DHA/EPAdrug

10 mg lutein and 2 mg zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)